FDA.reportPublic FDA data

Albuterol Sulfate

Product NDC
76204-200
11-digit product format
762040200
Labeler code
76204
Product ID
76204-200_4ffe0388-e743-7259-e063-6394a90a94d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albuterol Sulfate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Ritedose Pharmaceuticals, LLC
Application
ANDA077839
Marketing category
ANDA
Marketing start
2011-12-05
Substance
ALBUTEROL SULFATE
Active strength
2.5 mg/3mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Albuterol Sulfate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALBUTEROL SULFATE2.5 mg/3mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii021SEF3731
Rxcui630208

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
26005090-31a1-441d-920b-db3101a55d53Product name320250221
1c39b897-7219-42a1-9f3a-ec86cfd7b04bProduct name320250218
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0a278166-c8aa-41b6-b4a5-6ac332bde76aProduct name120230718
c76bcd0f-25eb-471e-b970-1956c95c26c5Product name120230425
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
36390b75-5438-47d3-af60-732a654e9025Product name220220110
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
387afa72-0c5a-0d6b-ee2c-60c3506659e8Product name620210518
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
1b8ea3ec-88bd-98ea-c961-00ae340b5b14Product name220200220
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
3aa5a017-61e9-0c89-adef-13e7964d22f0Product name320171208
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c3c27a99-b8bc-4955-841c-26555f58ee7eProduct name120150421
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
bc98cf6f-a973-7162-5e30-0e7dd8c56bc3Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76204-200-01Albuterol Sulfate30 in 1 CARTONSOLUTION3020
76204-200-01Albuterol Sulfate1 in 1 POUCHSOLUTION120
76204-200-25Albuterol Sulfate25 in 1 POUCHSOLUTION2520
76204-200-25Albuterol Sulfate1 in 1 CARTONSOLUTION120
76204-200-30Albuterol Sulfate1 in 1 CARTONSOLUTION120
76204-200-30Albuterol Sulfate30 in 1 POUCHSOLUTION3020
76204-200-60Albuterol Sulfate30 in 1 POUCHSOLUTION3020
76204-200-60Albuterol Sulfate2 in 1 CARTONSOLUTION220

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76204-200-01ML - Milliliter76204-20014f3189a-aabf-4273-81ff-3117fb53448e12013-11-04
76204-200-25ML - Milliliter76204-200222a6282-c73d-4d52-a540-16238cc6bac612012-07-24
76204-200-30ML - Milliliter76204-2000f1fa0ae-de95-4fd6-ade0-d8a844d2877012012-07-24
76204-200-60ML - Milliliter76204-200ca17bc17-793c-4595-af9a-71d667f2b84d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Albuterol SulfateACTIVE INGREDIENT021SEF3731ALBUTEROL SULFATE SOLUTION [RITEDOSE PHARMACEUTICALS, LLC]4
AlbuterolACTIVE MOIETYQF8SVZ843EALBUTEROL SULFATE SOLUTION [RITEDOSE PHARMACEUTICALS, LLC]4
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XALBUTEROL SULFATE SOLUTION [RITEDOSE PHARMACEUTICALS, LLC]4
Sulfuric AcidINACTIVE INGREDIENTO40UQP6WCFALBUTEROL SULFATE SOLUTION [RITEDOSE PHARMACEUTICALS, LLC]4
WaterINACTIVE INGREDIENT059QF0KO0RALBUTEROL SULFATE SOLUTION [RITEDOSE PHARMACEUTICALS, LLC]4
ALBUTEROL SULFATEACTIVE INGREDIENT021SEF3731ALBUTEROL SULFATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]1
ALBUTEROLACTIVE MOIETYQF8SVZ843EALBUTEROL SULFATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XALBUTEROL SULFATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]1
SULFURIC ACIDINACTIVE INGREDIENTO40UQP6WCFALBUTEROL SULFATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RALBUTEROL SULFATE SOLUTION [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76204-200ALBUTEROL SULFATE SOLUTION [RITEDOSE PHARMACEUTICALS, LLC]17Current NDC, Legacy NDC, 8 package rows20241219_b72742df-1a6b-4483-aff3-3e79db5e015d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
630208albuterol sulfate 0.083 % Inhalation SolutionPSN19867b61-77a2-46f1-97c7-7fadfec5882b22
630208albuterol 0.83 MG/ML Inhalation SolutionSCD19867b61-77a2-46f1-97c7-7fadfec5882b22
630208albuterol 0.083 % Inhalation SolutionSY19867b61-77a2-46f1-97c7-7fadfec5882b22
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSY19867b61-77a2-46f1-97c7-7fadfec5882b22
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSY19867b61-77a2-46f1-97c7-7fadfec5882b22
630208albuterol sulfate 0.083 % Inhalation SolutionPSNb72742df-1a6b-4483-aff3-3e79db5e015d20
630208albuterol 0.83 MG/ML Inhalation SolutionSCDb72742df-1a6b-4483-aff3-3e79db5e015d20
630208albuterol 0.083 % Inhalation SolutionSYb72742df-1a6b-4483-aff3-3e79db5e015d20
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSYb72742df-1a6b-4483-aff3-3e79db5e015d20
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSYb72742df-1a6b-4483-aff3-3e79db5e015d20
630208albuterol sulfate 0.083 % Inhalation SolutionPSNd2132c1c-0f90-4c6f-afc0-f3814b6a7e5c6
630208albuterol 0.83 MG/ML Inhalation SolutionSCDd2132c1c-0f90-4c6f-afc0-f3814b6a7e5c6
630208albuterol 0.083 % Inhalation SolutionSYd2132c1c-0f90-4c6f-afc0-f3814b6a7e5c6
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSYd2132c1c-0f90-4c6f-afc0-f3814b6a7e5c6
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSYd2132c1c-0f90-4c6f-afc0-f3814b6a7e5c6
630208albuterol sulfate 0.083 % Inhalation SolutionPSN6a4b4b95-d1d3-9051-e053-2a91aa0a52e83
630208albuterol sulfate 0.083 % Inhalation SolutionPSN2c3f975c-dbd8-0362-e063-6394a90a16dd3
630208albuterol 0.83 MG/ML Inhalation SolutionSCD6a4b4b95-d1d3-9051-e053-2a91aa0a52e83
630208albuterol 0.83 MG/ML Inhalation SolutionSCD2c3f975c-dbd8-0362-e063-6394a90a16dd3
630208albuterol 0.083 % Inhalation SolutionSY6a4b4b95-d1d3-9051-e053-2a91aa0a52e83
630208albuterol 0.083 % Inhalation SolutionSY2c3f975c-dbd8-0362-e063-6394a90a16dd3
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSY6a4b4b95-d1d3-9051-e053-2a91aa0a52e83
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSY2c3f975c-dbd8-0362-e063-6394a90a16dd3
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSY6a4b4b95-d1d3-9051-e053-2a91aa0a52e83
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSY2c3f975c-dbd8-0362-e063-6394a90a16dd3
630208albuterol sulfate 0.083 % Inhalation SolutionPSN05f7916c-52f7-4a4f-a19b-f5e35f02fd0b1
630208albuterol 0.83 MG/ML Inhalation SolutionSCD05f7916c-52f7-4a4f-a19b-f5e35f02fd0b1
630208albuterol 0.083 % Inhalation SolutionSY05f7916c-52f7-4a4f-a19b-f5e35f02fd0b1
630208albuterol 0.83 MG/ML (albuterol sulfate 1 MG/ML) Inhalation SolutionSY05f7916c-52f7-4a4f-a19b-f5e35f02fd0b1
630208albuterol 2.5 MG per 3 ML Inhalation SolutionSY05f7916c-52f7-4a4f-a19b-f5e35f02fd0b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76204-200-017620402000130 POUCH in 1 CARTON (76204-200-01) / 1 AMPULE in 1 POUCH / 3 mL in 1 AMPULE30 pouch2011-12-050000-00-00NoNoCurrent
76204-200-25762040200251 POUCH in 1 CARTON (76204-200-25) / 25 AMPULE in 1 POUCH / 3 mL in 1 AMPULE1 pouch2011-12-050000-00-00NoNoCurrent
76204-200-30762040200301 POUCH in 1 CARTON (76204-200-30) / 30 AMPULE in 1 POUCH / 3 mL in 1 AMPULE1 pouch2011-12-050000-00-00NoNoCurrent
76204-200-60762040200602 POUCH in 1 CARTON (76204-200-60) / 30 AMPULE in 1 POUCH / 3 mL in 1 AMPULE2 pouch2011-12-050000-00-00NoNoCurrent